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OpenTrials
Completed

NCT Number: NCT02279303

Rx for Better Breast Health

This randomized controlled trial will test the impact of a patient-navigated, anti-inflammatory, culinary-based intervention (reinforced by motivational interviewing [MI] and tailored newsletters) on obese (body mass index [BMI] 30+), early-stage (0-IIIA) breast cancer survivors compared to a control group.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

About this study

The investigators will recruit English-speaking, early-stage breast cancer survivors (N=200) to a two-arm randomized controlled trial (RCT) involving a 2 (group) by 3 (time) repeated measures design. The intervention will stimulate dietary behavior changes using individualized anti-inflammatory dietary prescriptions with six monthly workshops (culinary demonstrations, recipes and meal planning) and behavior change cures reinforced through evidence- and theory-based patient navigation, motivational interviewing, and tailored newsletters personalized to individual readiness for change. Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments. Groups will be compared at baseline and 6- and 12-month follow-up. Dependent measures will include dietary behavior and levels of cancer-associated biomarkers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females 18 years or older
  • Primary diagnosis of breast cancer
  • Fluency in English
  • B.M.I. >= 30
  • Available for follow-up for 12 months

Exclusion criteria

  • Clinical evidence of metastatic disease
  • Not diagnosed with primary breast cancer
  • Lack fluency in English
  • B.M.I. < 30

Treatment and study plan

Dietary intervention

Behavioral

Participants will receive individualized anti-inflammatory dietary prescriptions with six monthly workshops (culinary demonstrations, recipes and meal planning) and behavior change cures reinforced through evidence- and theory-based patient navigation, motivational interviewing, and tailored newsletters personalized to individual readiness for change.

Dietary Control

Behavioral

Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments.

Primary outcomes

  1. Achieve USDA-recommended dietary intake based on five major food groups

    Time frame: 12 months

    The USDA has published dietary intake guidelines for 5 major food groups. We will create a composite score ("yes" vs. "no") describing whether ss achieve designated levels of dietary intake for all five food groups. We will compare proportions of study and control women achieving this target at 12-month follow-up controlling for baseline values.

  2. Intervention versus Control group comparison of circulating Adipose Stromal Cells (ASCs) at follow-up

    Time frame: 12 months

    We will compare participant (intervention) versus control levels of circulating Adipose Stromal Cells (ASCs) at 12-month follow-up. Participant levels of ASCs will be significantly lower than controls, controlling for baseline values.

  3. Comparison of Interleukin (IL) pro-inflammatory biomarkers

    Time frame: 12 months

    We will compare participant versus control levels of Interleukins IL3, IL6, IL8 at 12-month follow-up. Participant levels of IL3, IL6, and IL8 will be significantly lower than controls, controlling for baseline values.

  4. Comparison of Interleukin (IL) anti-inflammatory biomarkers

    Time frame: 12 months

    We will compare participant versus control levels of Interleukin IL10 at 12-month follow-up. Participant levels of IL10 will be significantly lower than controls, controlling for baseline values.

  5. Comparison of C-Reactive Protein (CRP)

    Time frame: 12 months

    We will compare participant versus control levels of C-Reactive Protein (CRP) at 12-month follow-up. Participant levels of CRP will be significantly lower than controls, controlling for baseline values.

  6. Comparison of Tumor Necrosis Factor-alpha (TNF-alpha)

    Time frame: 12 months

    We will compare participant versus control levels of Tumor Necrosis Factor-alpha (TNF-alpha) at 12-month follow-up. Participant levels of TNF-alpha will be significantly lower than controls, controlling for baseline values.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • Susan G. Komen Breast Cancer Foundation

Registry information

Official study title

Prescription for Better Breast Health

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2014
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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